Senior Regulatory Affairs Specialist

Vor 2 Tagen

Neuss, Nordrhein-Westfalen, Deutschland Kenvue Vollzeit
Job Title: Senior Regulatory Affairs Specialist

At Kenvue, we are seeking a highly skilled Senior Regulatory Affairs Specialist to join our team in Neuss, Germany. As a key member of our Regulatory Affairs function, you will be responsible for developing and implementing regulatory strategies across the EMEA region and globally.

Key Responsibilities:
  • Manage and coach a team of regulatory professionals to ensure effective regulatory compliance and strategy implementation.
  • Evaluate and coordinate regulatory deliverables for cosmetic and medical devices within your geographical and/or brand area of responsibility.
  • Develop effective partnerships with R&D, Franchise, and local regulatory colleagues to drive regulatory outcomes.
  • Assist in the preparation of dossiers and submission packages for product registration and maintenance throughout their lifecycle.
  • Represent the Regulatory Affairs function within the Skin &/or Essential Health Franchise.
Regulatory Strategy:
  • Work with local and regional regulatory colleagues to develop global and/or regional regulatory strategies, coordinating regulatory actions and results.
  • Develop global/regional dossiers to support local review processes.
  • Organize materials from preclinical and clinical studies for review and assist in the review process.
  • Prepare and submit regulatory submissions according to applicable regulatory requirements and guidelines.
  • Assist in scheduling meetings with internal stakeholders and regulators, developing and organizing materials for these meetings.
Regulatory Compliance:
  • Maintain logs of communication and outcomes with regulators and other relevant internal or external stakeholders.
  • Maintain awareness of current regulations and anticipate implications and opportunities as a result of changes to the relevant regulatory environments.
  • Participate in the development and implementation of, and maintain compliance with, all applicable processes, SOPs, and working instructions.
  • Ensure that enterprise Regulatory systems are accurate and fully maintained.
  • Ensure any compliance issues are reviewed and escalated, and relevant corrective/preventative actions are implemented locally.
Regulatory Advocacy:
  • Monitor the regulatory environment and maintain information resources.
  • Support trade association, working groups, developing impact assessments, influencing strategies, and leading solutions at EU and local level (if relevant).

Requirements:

  • Partners with the business to deliver regulatory outcomes to enable committed business plans within area of responsibility.
  • Works with strategic direction to perform with independent judgment and execution, which directly impacts the operational results of the business unit.

Other Features of the Job:

  • Represents Regulatory Affairs on cross-functional product/project teams and provides regulatory advice.
  • Uses effective communication and employs influencing skills to continue to grow key relationships with internal/external contacts.

Qualifications:

Primary Location: Europe/Middle East/Africa-Germany-North Rhine Westphalia-Rhein-Kreis Neuss

Job Function: Regulatory Affairs

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